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PUBLIC HEALTH DIVISION Immunization Program

Model Immunization Protocol PNEUMOCOCCAL CONJUGATE VACCINE: PCV13 (Prevnar13)

AND PNEUMOCOCCAL POLYSACCHARIDE VACCINE: PPSV23 (Pneumovax23) Last Reviewed 31 March 2021 Last Updated 4 June 2020

This order expires 30 June 2022

Table of contents What’s new ................................................................................................................. 1

1. Oregon model immunization protocol ................................................................... 3

2. Vaccine schedule for pneumococcal vaccines ...................................................... 4

3. Licensed pneumococcal vaccines ........................................................................ 4

5. Recommendations for use of PCV13 .................................................................... 4

6. Recommendations for use of PPSV23 .................................................................. 7

6. Contraindications .................................................................................................. 8

7. Warnings and precautions .................................................................................... 8

8. Other considerations ............................................................................................ 8

9. Side effects and adverse reactions ..................................................................... 10

10. Storage and handling ......................................................................................... 10

11. Adverse events reporting .................................................................................... 11

12. References ......................................................................................................... 11

13. Appendices ......................................................................................................... 13

What’s new3

PCV13 is no longer routinely recommended for all healthy adults ≥65 years of age, due to sharp declines in pneumococcal disease among adults and children. Local Public Health Authorities MUST have a prescription, or an order from a prescriber, in order to vaccinate this population

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Adults with certain immunocompromising conditions should still receive a dose of PCV13 at age 65 years. The decision of whether to vaccinate an adult ≥65 years of age who does not have an immunocompromising condition and who has not previously received PCV13 should be a shared clinical decision between the patient and their medical provider.

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1. Oregon model immunization protocol A. Check the ALERT Immunization Information System (IIS) to determine

whether the patient needs this vaccine and any other vaccines. B. Screen clients for contraindications. C. Provide a current Vaccine Information Statement (VIS), answering any

questions. D. Record all required data elements in the client’s permanent health record. E. Verify needle length for IM injection into the vastus lateralis or deltoid.

PPSV23 may also be given by SQ injection into the fatty tissue over the triceps with a 5/8” needle.

F. To avoid shoulder injury related to vaccine administration, make sure staff who administer vaccines recognize the anatomic landmarks for identifying the deltoid muscle and use proper intramuscular administration technique.9 See appendices for additional information.

G. Pneumococcal vaccines: 1) Give 0.5 mL PCV13 vaccine (Prevnar13)2 intramuscularly (IM) to eligible

clients. See Section 5. A–C; OR 2) Give 0.5 mL PPSV23 vaccine (Pneumovax 23)1 IM, or subcutaneously

(SC) to eligible clients. See Section 6. I. H. PCV13 and PPSV23 should not be given at the same time.4 Either vaccine

may be given simultaneously with influenza and most other ACIP-recommended child and adult vaccinations.

I. Ask client to remain seated on the premises for 15 minutes after vaccination to decrease the risk of injury should they faint.

J. This order does not cover Advisory Committee on Immunization Practices (ACIP) recommendations that involve shared clinical decision making. Shared clinical decision making means the decision to vaccinate should be based on a discussion of benefits and risks between the patient and the clinician, and the clinician would then prescribe the vaccine.

Health Officer Signature Date Health Officer Signature Date

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2. Vaccine schedule for pneumococcal vaccines

Vaccine Schedule: Pneumococcal Conjugate Vaccine (PCV13)2 Age Group Dose No. of Doses Route ≥6 weeks 0.5 mL Varies by age Intramuscular

Vaccine Schedule: Pneumococcal Polysaccharide Vaccine (PPSV23)1

Age Group Dose No. of Doses Route ≥2 years 0.5 mL Varies by age Intramuscular or Subcutaneous

3. Licensed pneumococcal vaccines

Pneumococcal Conjugate Vaccine (PCV13) Trade Name Presentation Acceptable Age Range Prevnar 13®2 0.5-mL prefilled syringes ≥6 weeks

Pneumococcal Polysaccharide Vaccine (PPSV23) Trade Name Presentation Acceptable Age Range

Pneumovax 23®1 0.5-mL single-dose vials

≥2 years 0.5-mL prefilled syringes 2.5-mL five-dose vial

5. Recommendations for use of PCV13 A. Routine Schedule for PCV13

All infants aged ≥2 months without contraindications. First dose may be given as early as 6 weeks of age.

Routine Pneumococcal Conjugate Vaccine (PCV13)6 Dose Preferred Age Minimum acceptable

age Minimum Acceptable

Spacing 1 2 months 6 weeks

2 4 months 10 weeks 4 weeks after dose 1

3 6 months 14 weeks 4 weeks after dose 2

4 12–15 months 12 months 8 weeks after dose 3

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B. Catch-Up Schedule for PCV13

Catch-Up Pneumococcal Conjugate Vaccine (PCV13)6 Age Doses received

previously Recommended PCV13 regimen Total doses

in series

4–6 months

0 doses 3 doses, 4 weeks apart; 4th dose at age 12–15 months 4

1 dose

2 doses, 4 weeks apart; 4th dose at age 12–15 months 4

2 doses

1 dose, 4 weeks after most recent dose; 4th dose at 12–15 months 4

7–11 months

0 doses 2 doses, 4 weeks apart; 3rd dose at 12–15 months 3 1 or 2 doses before age 7

months

1 dose at 7–11 months, with a 2nd dose at 12–15 months ≥8 weeks afterwards 3 or 4

12–23 months

0 doses 2 doses ≥8 weeks apart 2 1 dose <12

months of age 2 doses ≥8 weeks apart 3

1 dose at age ≥12 months if age 1 dose ≥8 weeks after most recent dose 2

2 or 3 doses at <12 months of age 1 dose ≥8 weeks after most recent dose 3 or 4

24–59 months

0 doses 1 dose 1 1 dose 1 dose 2

2 doses <24 months of age 1 dose 3

2 doses, at least 1 dose at ≥12

months of age Series complete 2

3 doses, all <12 months of age 1 dose 4

3 doses, at least 1 dose at ≥12

months of age Series complete 3

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C. Persons with Special Indications for PCV13

Pneumococcal Conjugate Vaccine (PCV13) for Persons Aged ≥2 Years of Age with Underlying Conditions

Age Previous PCV Vaccination History Recommended PCV13 Regimen

2 years through 5 years of age6 with chronic conditions●*

Unvaccinated or less than 3 doses before age 24 months

2 doses, with ≥8 weeks between each dose

3 doses before age 24 months 1 dose ≥8 weeks after the most recent dose

4 doses before age 24 months Complete

6–18 years of age with high-risk* conditions5

Unvaccinated with PCV13 1 dose ≥8 weeks after PPSV23

≥1 dose of PCV13 Complete

≥19 years of age with high-risk* conditions1

Unvaccinated with PCV13 or PPSV23 1 dose

≥1 dose of PCV13 Complete

Previous vaccination with PPSV23 1 dose ≥1 year after the last PPSV23 dose

● Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy), diabetes mellitus.

*CSF leak, cochlear implant, sickle cell disease and other hemoglobinopathies, asplenia, HIV infection, chronic renal failure, nephrotic syndrome, immunodeficiency, diseases treated with immunosuppressive therapy or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma.

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6. Recommendations for use of PPSV23 A. Routine Schedule for PPSV23

B. Persons with Special Indications for PPSV23

Pneumococcal Polysaccharide Vaccine (PPSV23) for Children Aged ≥2 Years of Age and Adults with Underlying Conditions7 Age Previous PPV23

Vaccination History Recommended PPV23

Regimen Revaccinate after 5

years? ≥2 years — immunocompetent with chronic conditions●6

Unvaccinated 1 dose ≥8 weeks after any PCV doses No

1 dose Complete No

≥2 years — immunocompromised with high-risk conditions*6,7

Unvaccinated 1 dose ≥8 weeks after any PCV doses

Yes, then final dose at age 65 years

1 dose 1 dose ≥5 years after last dose and ≥8 weeks after any PCV doses.

No, final dose at age 65 years

● Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy), chronic liver disease, diabetes mellitus, alcoholism, cigarette smoking. *CSF leak, cochlear implant, sickle cell disease and other hemoglobinopathies, asplenia, HIV infection, chronic renal failure, nephrotic syndrome, immunodeficiency, diseases treated with immunosuppressive therapy or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma.

Routine Pneumococcal Polysaccharide Vaccine (PPSV23)

Age Previous PPV23 Vaccination History

Recommended PPSV23 Regimen

≥65 years1,3

Unvaccinated 1 dose

≥1 previous dose ≤65 years 1 dose ≥5 years after previous dose

≥1 previous dose ≥65 years Complete

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6. Contraindications PCV132

A. Persons who experienced an anaphylactic reaction to a previous dose of PCV7, PCV13 or any diphtheria toxoid-containing vaccine.

B. Do not give Menactra (MenACWY-D) to children ≤2 years of age with functional or anatomic asplenia, including sickle cell, due to potential interference with the immune response to PCV13. (Because MenACWY-CRM [Menveo®] has not demonstrated immune interference with PCV7 after the 12-month dose, MenACWY-CRM can be administered concomitantly with PCV13).8

C. Allergy to soy peptones.

PPSV231 A. Persons who experienced an anaphylactic reaction to a previous dose of

pneumococcal vaccine or a vaccine component.

7. Warnings and precautions PCV13 and PPSV231,2 A. Women who are at high risk of pneumococcal disease and who are candidates

for either PCV13 or PPSV23 should be vaccinated before pregnancy, if possible. B. Persons with acute, moderate or severe illness with or without fever may choose

to delay immunization until symptoms have improved. PPSV231 A. Care should be exercised when administering to patients with severely

compromised cardiovascular or pulmonary function in whom a systemic reaction would pose a significant risk.

8. Other considerations A. Adverse Events: Epinephrine hydrochloride solution (1:1,000) and other

appropriate agents and equipment must be available for immediate use in case of anaphylactic or acute hypersensitivity reaction.9

B. Lactation: It is not known whether pneumococcal vaccines are excreted in human milk. Use with caution in nursing mothers.1,2

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C. Simultaneous administration of PCV13 and PPSV23 is NOT recommended. See sections 5 and 6, recommendations for use, for the necessary minimum interval between doses.4

D. May give influenza and zoster vaccines at same visit as PPSV23.1 E. When an elective splenectomy is performed for any reason, administer PPSV23

at least 8 weeks after the last dose of PCV13 and at least 2 weeks prior to splenectomy. If pneumococcal vaccine is not administered before surgery, it should be administered ≥2 weeks after surgery. If the patient is unlikely to return, vaccine can be administered in the immediate post-operative period.6

F. Immunization should precede the initiation of immunocompromising therapy by at least two weeks.6

G. Children who have experienced invasive pneumococcal disease should receive all recommended doses of a pneumococcal conjugate vaccine as appropriate for their age and underlying condition. The full series of scheduled doses should be completed even if the series is interrupted by an episode of invasive pneumococcal disease.

H. Individuals with diseases associated with immunosuppressive therapy or radiation therapy and solid organ transplantation may have a diminished response to the vaccine.1,2

I. ACIP recommends that one dose of PPSV23 be given to a hematopoietic stem cell transplant (HSCT) recipient ≥8 weeks the last dose of PCV13.9

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9. Side effects and adverse reactions

10. Storage and handling All clinics and pharmacies enrolled with the Vaccines for Children (VFC) Program must immediately report any storage and handling deviations to the Oregon Immunization Program at 971-673-4VFC (4823).

Vaccine Discard Latex Temp Storage Issues

Prevnar 132 N/A No 2○– 8○C

Vaccine is stable at temperatures up to 25○C for up to 4 days—not recommended for storage or shipping

Pneumovax 231

Use opened multi-dose vials through the expiration date

None

PCV132 Infants and children Irritability, soreness at the injection site Very common, up to 80% Decreased appetite, decreased sleep, increased sleep Common, up to 50%

Fever, erythema, induration at injection site Common, up to 30% Allergic reactions Rare Adults Soreness at the injection site, fatigue Common, up to 50% Headache, muscle pain, joint pain, decreased appetite, local swelling, decreased arm movement

Uncommon, up to 20%

Vomiting, fever, chills, rash Rare, up to 5% Allergic reactions Rare PPSV231 Soreness, redness, swelling at the injection site Common, up to 60% Headache, muscle pain, fatigue Uncommon, up to 20% Nausea, fever, chills Rare, up to 2% Allergic reactions Rare

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11. Adverse events reporting Report suspected adverse events to the Vaccine Adverse Events Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html. VAERS Reporting Table: https://vaers.hhs.gov/resources/infoproviders.html

Event and interval from vaccination A. Shoulder Injury Related to Vaccine Administration (7 days) B. Vasovagal syncope (7 days) C. Any acute complication or sequelae (including death) of above events

(interval—not applicable) D. Events described in manufacturer’s package insert as contraindications to

additional doses of vaccine (interval—see package insert).

12. References 1. Merck and Co. Pneumovax®23 (PPSV23) 2019 package insert. Available at:

www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf 2. Wyeth Pharmaceuticals, Inc. Prevnar®13 (PCV13) 2019 package insert. Available

at: http://labeling.pfizer.com/showlabeling.aspx?id=501 3. Matanock A, Lee G, Gierke R, et al. Use of 13-valent pneumococcal conjugate

vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 Years: updated recommendations of the Advisory Committee on Immunization Practices. MMWR 2019;68(46);1069–75. Accessed 11 December 2019.

4. Kobayashi M, Bennett NM, Gierke R, et al. Intervals between PCV13 and PPSV23 vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2015;64(34):944–7. Accessed 11 December 2019.

5. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6–18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2013;62(25):521–4. Accessed 11 December 2019.

6. Nuorti JP, Whitney CG. Prevention of pneumococcal disease among infants and children — use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2010;59(RR11);1–18.

7. CDC. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising

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conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2012;61(40):816–9. Accessed 27 January 2020.

8. MacNeil JR, Rubin L, McNamara L, Briere EC, Clark TA, Cohn AC. Use of MenACWY-CRM vaccine in children aged 2 through 23 months at increased risk for meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2013. MMWR 2014; 63(24):527–30. Accessed 04 June 2018.

9. Ezeanolue E, Harriman K, Hunter P, Kroger A. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed 19 December 2019.

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13. Appendices Table 1 ACIP RECOMMENDATIONS FOR SEQUENTIAL ADMINISTRATION AND RECOMMENDED INTERVALS FOR PNEUMOCOCCAL VACCINE-NAÏVE HIGH-RISK PERSONS 19–64 YEARS OF AGE: 4

Table 2 ACIP RECOMMENDATIONS FOR SEQUENTIAL ADMINISTRATION AND RECOMMENDED INTERVALS FOR HIGH-RISK PERSONS 19–64 YEARS OF AGE WITH PRIMARY PPSV23 IMMUNIZATION: 3

PPSV23 PPSV23

≥ 8 Weeks Apart

≥ 5 Years Apart

PCV13

PPSV23 PPSV23

≥ 1 Year Apart

≥ 8 Weeks since PCV13 and ≥5 years since the last dose

of PPSV23

PCV13

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